The prior art is replete with IUDs and IUD inserters for placing an IUD into a uterus of a patient. In the past, many attempts have been made to safely assure that the IUD will be placed at the proper depth at the uterine fundus. However, the prior art methods and apparatus for inserting an IUD have been inadequate in their attempts to achieve a satisfactory degree of safety while inserting the IUD. In one known prior art IUD inserter, formerly used by the applicant, the IUD inserter comprised a tubular cannula in which the IUD is stored, a flange connected to a portion of the cannula to indicate the proper depth of a patient's uterus and an elongate plunger sized and shaped to be inserted within the cannula. While the cannula containing the IUD is inserted into a patient's uterus to the uterine fundus, the IUD is forced from the cannula by the distal end of the associated plunger. This prior art IUD inserter depends solely on the skill of the operator for proper placement.
U.S. Pat. No. 3,918,444 to Hoff et al. is directed toward an IUD inserter apparatus comprising an elongate tube and a slidable cap having slots disposed therein to receive corresponding arm members of an associated IUD. The function of the cap is to restrain the arm members and to facilitate insertion of the IUD. The IUD inserter disclosed in the '444 patent likewise depends on the skill of the operator to achieve proper IUD placement and to avoid trauma to the uterine wall.
U.S. Pat. No. 3,927,666 to Hoff discloses an IUD inserter comprising an elongate tube having a small diameter section and a large diameter section for retaining an IUD therein. A collar is arranged around the circumference of the larger diameter section of the inserter tube. The collar abuts the cervix to arrest motion of the tube. Such a collar tends to reduce the likelihood of injury to the wall of a patient's uterus. The inserter of the '666 patent has obvious drawbacks in that the expandable arms of an associated T-shaped IUD must be aligned with the entrance of a patient's cervix for insertion into the uterus without the aid of an arm retainer or any guide means whatsoever.
Furthermore, packaging trays for IUDs and IUD inserters, as well as packaging for other medical instruments, are well-known in the art. With respect to trays for an IUD inserting apparatus, U.S. Pat. No. 4,019,633 to Roth discloses a package for an IUD and an IUD inserter comprising a thermoformed plastic tray having a cavity therein for holding an IUD and an IUD inserter, a cover therefor, and an adhesive coating for attaching the aforementioned cover to the plastic tray. As shown in FIG. 2 of the '633 patent, a cavity permits the arms of an IUD to remain in an expanded T-shaped position within a cap of an associated IUD inserter device. However, the foregoing tray is defective in that the IUD and its associated inserter must be removed from the sterilized environment of the tray prior to "loading" the arms of the IUD into cap of the IUD inserter so that the arms can be held in a substantially folded position.
Another IUD, IUD inserter and tray therefor manufactured by the German company Nourypharma GmbH and sold under the trade name MULTILOAD CU250. This device includes a tube-type inserter having a collar thereon such that the collar can directly abut the cervix upon insertion. A tray includes four separate compartments for retaining the collar. Additionally, the tray includes a scale consisting of the numerical indicia 6, 7, 8 and 9 cm arranged adjacent a respective compartment for retaining the collar. These compartments serve the purpose of retaining the collar and aligning it with a depth in centimeters corresponding to a uterus sounding measurement of a particular patient. The MULTILOAD CU250 tray includes several shortcomings which hamper the effectiveness and usefulness of the tray disclosed therein. In particular, the MULTILOAD CU250 tray does not include means for "loading" expandable arms of an IUD into an inserter immediately before inserting the IUD into the uterus of a patient. Additionally, the separate compartments for retaining the collar inhibit the precise setting of the collar to the proper depth for an individual patient. Furthermore, the MULTILOAD CU250 tray does not prevent the arms of an IUD from spinning or twisting prior to insertion or during insertion of the IUD into the cervical os. Thus, the arms of the IUD may not be properly aligned when the IUD is placed into the uterus of a patient.
Thus, despite all of the efforts in the prior art, improved methods and apparatus for inserting an IUD into the uterus of a patient are needed.